<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT201304096790N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-05-22</date_registration>
      <primary_sponsor>Ilam university of medical sciences</primary_sponsor>
      <public_title>Comparison The Effect Of Celecoxib And Ibuprofen On The treatment of Primary Dysmenorrhea on Students of Ilam Univercity of Medical Sciences</public_title>
      <acronym></acronym>
      <scientific_title>Comparison The Effect Of Celecoxib And Ibuprofen On The treatment of Primary Dysmenorrhea on Students of Ilam Univercity of Medical Sciences</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-04-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/7201</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Dysmenorrhea.</hc_freetext>
      <i_freetext>Intervention 1: In one of the groups in 2th cycle with onset of menstrual pain, participant use 1 tab of celecoxib 200 mg every 12h and in 3th cycle she should a tab of ibuprofen 400mg every 6-8h then she fill the questionnaire No:2. Intervention 2: In another group in 2th cycle with onset of pain the participants use 1 tab of ibuprofen 400mg every 6-8h and in 3th cycle 1 tab of celecoxib 200 mg every 12h, the questionnaire No:2 will be filled.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zainab suhrabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>banganjab- Pajohesh Blvd.</address>
        <city>Ilam</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 84 1222 7123</telephone>
        <email>suhrabi2007@yahoo.comsuhrabi-z@medilam.ac.ir</email>
        <affiliation>Ilam university of medical sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zainab suhrabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Banganjab- Pajohesh Blvd.</address>
        <city>Ilam</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 84 1222 7123</telephone>
        <email>suhrabi2007@yahoo.comsuhrabi-z@medilam.ac.ir</email>
        <affiliation>Ilam university of medical sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>This is double-blinded crossing trial that will be perform in two dormatorse(khayam and kawsar) of students affiliated to ilam university of medical science. The aim of study is to survay the effect of celecoxib and iboprofen on primary dysmenorrhea in 80 girl students. Inclusion criteria including age 18-22 y-o, presence of menstrual pains among recent 6 month. Exclusion criteria including history of abdomenal/ pelvic surgery and usage of OCPs. The samples will be select  by convenience method then assigned to two groups of celecoxib – ibuprofen and celecoxib – ibuprofen. Each of participants evaluated for 3 menstrual cycles. That in first we take no intervention and the participant should record its pain severity and duration with Andrish-Melisum, VAS scale and a watch. In one of the groups in 2th cycle with onset of menstrual pain, participant use 1 tab of celecoxib 200 mg every 12h and in 3th cycle she should a tab of ibuprofen 400mg every 6-8h then she fill the questionnaire No:2. In another group in 2th cycle with onset of pain the participants use 1 tab of ibuprofen 400mg every 6-8h and in 3th cycle 1 tab of celecoxib 200 mg every 12h, the questionnaire No:2 will be filled.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>22 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N94.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>primary dysmenorrhea</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In one of the groups in 2th cycle with onset of menstrual pain, participant use 1 tab of celecoxib 200 mg every 12h and in 3th cycle she should a tab of ibuprofen 400mg every 6-8h then she fill the questionnaire No:2</i_keyword>
      <i_keyword>In another group in 2th cycle with onset of pain the participants use 1 tab of ibuprofen 400mg every 6-8h and in 3th cycle 1 tab of celecoxib 200 mg every 12h, the questionnaire No:2 will be filled.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Intensity of menstural pain. Timepoint: befor and 1,2,3,4,6,8,12,24,48 and 72 hour after intervention. Method of measurement: VAS scale.</prim_outcome>
      <prim_outcome>Duration of menstural pain. Timepoint: onset of pain to stop. Method of measurement: watch.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Ilam university of medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-03-02</approval_date>
        <contact_name>Ilam university of medical sciences</contact_name>
        <contact_address>banganjab- pajohesh Blvd. Ilam  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
